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临床试验/NCT01209273
NCT01209273已完成不适用

Prospective, Observational and Multi-center Study of a Comparison of Quality of Life on Automated Peritoneal Dialysis and Continuous Ambulatory Peritoneal Dialysis

Kyungpook National University Hospital11 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
260
试验地点
11
主要终点
Change in Quality of Life

研究概览

简要总结

The objective of this study is to compare Quality of Life (QoL) between Automated Peritoneal Dialysis (APD) and Continuous Ambulatory Peritoneal Dialysis (CAPD).

详细描述

Automated peritoneal dialysis (APD) was first described in 1981, 5 years after the introduction of continuous ambulatory peritoneal dialysis (CAPD). It is increasingly used increasingly used in comparison with CAPD from 20% in 1995 to more than 33% of PD patients in North America in 1998, and in 2000, 54% of PD patients in the United States performed some form of APD.

APD has been several advantages over CAPD such as reduced incidence of peritonitis, mechanical complications and greater psychosocial acceptability. Many studies demonstrated a benefit for APD. In one Mexican retrospective study, APD has a better technical survival than CAPD with improvement of 1st peritonitis episode and French registry data showed the better peritonitis-free probability and autonomy in APD compared to CAPD. One study found that peritonitis rates and hospitalization were significantly less in patients on APD when results were expressed as episode/patient-year. Also a small randomized clinical trial comparing APD and CAPD showed that APD can help to keep selected patients vocationally or socially active.

Although APD has been expected to improve better condition of peritoneal dialysis patients, convincing evidence of major advantages is lacking and a benefit for APD is not demonstrated.

In three of randomized clinical trials, APD, APD did not differ from CAPD with respect to mortality (RR 1.49, 95% CI 0.51 to 4.37), risk of peritonitis(RR 0.75, 95% CI 0.50 to 1.11), switching from original PD modality to a different dialysis modality(RR 0.50, 95% CI 0.25 to 1.02), hernias(RR 1.26, 95% CI 0.32 to 5.01), PD fluid leaks(RR 1.06, 95% CI 0.11 to 9.83), PD catheter removal ( RR 0.64, 95% CI 0.27 to 1.48) or hospital admissions (RR0.96, 95% CI 0.43 to 2.17). In addition APD has potential disadvantages compared with CAPD like a possible faster in residual renal function, less sodium removal and more peritoneal protein loss and more expensive than CAPD. All of three large cohorts, NECOSAD, USRDS and ANZDATA showed that the risk of technical failure was not different between APD and CAPD but similar.

Because results on comparison between APD and CAPD is vague, prospective, observational and multi-center study in incident patients are required to gain more insight into survival on APD compared with CAPD in the course of peritoneal dialysis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female subjects at least 20 and older at that time of obtaining informed consent
  • Subjects performing CAPD or APD
  • Subject with a total Kt/V≥ 1.7 at baseline

排除标准

  • Subjects who have undergone abdominal surgery within the last 30 days except for PD catheter insertion
  • Subjects who is planned for renal transplantation or hemodialysis within 1 year following the date of informed consent
  • Subjects who have received antibiotics for the treatment of peritonitis, exit-site or tunnel infection within the last 30 days
  • Subjects who have active liver disease such as cirrhosis of the liver, active hepatitis or other active liver disease as evidenced by biopsy, laboratory (unstable liver enzymes over the last 90 days) or clinical examination.

结局指标

主要结局

Change in Quality of Life

时间窗: 1yr

change in quality of life and patient satisfaction scores from start to dialysis to 1yr between APD group and CAPD group.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yong-Lim Kim

Professor

Kyungpook National University Hospital

研究点 (11)

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